Grace-Marie Turner: First Biosimilar Poised For FDA Approval

Patients and payers have been anxiously awaiting approval of the first “biosimilar” medicines in the United States, hoping the new biologics will lower the cost of these often lifesaving treatments.

But early statements from makers of the first of these drugs likely to reach the market indicate that the company expects to launch its biosimilar at parity with the brand-name drug, a decision which would disappoint patients, policymakers, and payers, including Medicare.

The FDA is expected to soon approve Zarxio, a drug that is biologically similar to Amgen’s Neupogen which is injected as part of the treatment for cancer patients receiving chemotherapy, for patients with abnormally low counts of white blood cells, and other indications.

Zarxio is a product of Sandoz Biopharmaceuticals which already sells its Neupogen biosimilars in more than 40 countries outside the United States.

Mark McCamish, Sandoz’s global head of biopharmaceuticals and oncology injectables development, recently told a Food and Drug Administration panel that sometimes the product might be priced “at parity,” but that overall Zarxio would save the system money through rebates or other mechanisms.

“The cost will be less, to the consumer, to the payer, to the healthcare economy — otherwise it doesn’t make sense,” he told the panel.

Other Neupogen biosimilars are in the pipeline, and the “other mechanisms” that could drive down the price could well be free market competition. Experience with pricing of Gilead Hepatitis C drug, Sovaldi, is instructive.